510(k) · Cleared
ClearedCastleLoc-P Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 6, 2026 as substantially equivalent to K231839 (L&K BIOMED Co., Ltd., 2023) and 1 other predicate after a 33-day review. Its family tree reaches back 21 generations to 1985. 1 of the 278 devices in its family, counting itself, has a Class I recall.
- Decided
- May 6, 2026
- Review
- 33 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K853033 (1985). 277 ancestors in all. No later device cites it as a predicate yet. 1 of the 278 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations between
- 3 generations backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- 2 generations backK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- 1 generation backK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- This deviceK261112 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 20 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 19 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 18 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 17 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 16 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 15 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 14 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 13 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 12 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 11 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 10 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 9 generations backK142741 OASYS SystemStryker Corporation · 2015
- 8 generations backK150753 OASYS SystemStryker Corporation · 2015
- 7 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 6 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 5 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 4 generations backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- 3 generations backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- 2 generations backK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- 1 generation backK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- This deviceK261112 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
Class I recalls in this family
- K093670 Modification to: Oasys System9 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −20 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −19 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −18 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −17 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −16 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −15 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −14 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −13 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −12 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −11 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −10 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −9 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −8 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −7 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| −6 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| −5 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| −4 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| −3 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| −2 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| −1 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| 0 (this device) | K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 8 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 15 | 0 |
| 2002 | 16 | 0 |
| 2003 | 15 | 0 |
| 2004 | 14 | 0 |
| 2005 | 19 | 0 |
| 2006 | 21 | 0 |
| 2007 | 10 | 0 |
| 2008 | 15 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 9 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemSummary page 5…888.3060 Product Code(s) KWQ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231839 CastleLoc-P Anterior Cervical Plate System KWQ K143271 CastleLoc-P Anterior Cervical Plate System KWQ Device Description Summary… | 2023 |
| * | K143271 | CastleLoc-P Anterior Cervical Plate SystemSummary page 5…cate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231839 CastleLoc-P Anterior Cervical Plate System KWQ K143271 CastleLoc-P Anterior Cervical Plate System KWQ Device Description Summary 21 CFR 807.92(a)(4) The CastleLoc-P Anterior Cervical… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 9 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 25 of the 277 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K231839.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Castleloc-P Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
• degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors,
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudoarthrosis,
• failed previous fusion,
• spinal stenosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261112: CastleLoc-P Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261112
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026